Trial Outcomes & Findings for Investigation on Failure Time Analysis of a New TPE Material in the Iceform Liner (NCT NCT05040165)
NCT ID: NCT05040165
Last Updated: 2026-08-20
Results Overview
Number of study liners that experienced TPE material failure by the specified time point. TPE material failure was defined as any defect, cracking, tearing, or other failure of the thermoplastic elastomer material.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
3 months
Results posted on
2026-08-20
Participant Flow
Participant milestones
| Measure |
Failure Time Analysis
The primary objective is to evaluate the durability of the investigational device over its intended use lifetime (i.e. warranty period), specifically relating to any defect in the TPE material. Additionally, to gather information on the rate of side-effects, i.e. skin rashes, sores, etc.
Secondary objectives relate to gather information on how amputees use the liner, specifically:
* Intensity of use (days/week and hours/day)
* Alternation; i.e. switching every other day between liners
* Use of personal hygiene or cosmetic products
The following performance and safety aspects are to be verified:
• The ICEFORM line of devices are durable over their intended use lifetime.
Iceform liner and sleeve: Subjects will be asked to use the investigational device as their primary prosthesis for up to 6 months. TPE material durability evaluated through monthly online questionnaires.
|
|---|---|
|
Overall Study
STARTED
|
64
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
34
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Failure Time Analysis
n=64 Participants
The primary objective is to evaluate the durability of the investigational device over its intended use lifetime (i.e. warranty period), specifically relating to any defect in the TPE material. Additionally, to gather information on the rate of side-effects, i.e. skin rashes, sores, etc.
Secondary objectives relate to gather information on how amputees use the liner, specifically:
* Intensity of use (days/week and hours/day)
* Alternation; i.e. switching every other day between liners
* Use of personal hygiene or cosmetic products
The following performance and safety aspects are to be verified:
• The ICEFORM line of devices are durable over their intended use lifetime.
Iceform liner and sleeve: Subjects will be asked to use the investigational device as their primary prosthesis for up to 6 months. TPE material durability evaluated through monthly online questionnaires.
|
|---|---|
|
Age, Continuous
|
61 years
n=64 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=64 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=64 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Participants with recorded data on liner failure.
Number of study liners that experienced TPE material failure by the specified time point. TPE material failure was defined as any defect, cracking, tearing, or other failure of the thermoplastic elastomer material.
Outcome measures
| Measure |
Failure Time Analysis
n=35 Participants
The primary objective is to evaluate the durability of the investigational device over its intended use lifetime (i.e. warranty period), specifically relating to any defect in the TPE material. Additionally, to gather information on the rate of side-effects, i.e. skin rashes, sores, etc.
Secondary objectives relate to gather information on how amputees use the liner, specifically:
* Intensity of use (days/week and hours/day)
* Alternation; i.e. switching every other day between liners
* Use of personal hygiene or cosmetic products
The following performance and safety aspects are to be verified:
• The ICEFORM line of devices are durable over their intended use lifetime.
Iceform liner and sleeve: Subjects will be asked to use the investigational device as their primary prosthesis for up to 6 months. TPE material durability evaluated through monthly online questionnaires.
|
|---|---|
|
Number of Liners With TPE Material Failure
|
0 Liners
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Participants with recorded data on liner failure.
Number of study liners that experienced TPE material failure by the specified time point. TPE material failure was defined as any defect, cracking, tearing, or other failure of the thermoplastic elastomer material.
Outcome measures
| Measure |
Failure Time Analysis
n=30 Participants
The primary objective is to evaluate the durability of the investigational device over its intended use lifetime (i.e. warranty period), specifically relating to any defect in the TPE material. Additionally, to gather information on the rate of side-effects, i.e. skin rashes, sores, etc.
Secondary objectives relate to gather information on how amputees use the liner, specifically:
* Intensity of use (days/week and hours/day)
* Alternation; i.e. switching every other day between liners
* Use of personal hygiene or cosmetic products
The following performance and safety aspects are to be verified:
• The ICEFORM line of devices are durable over their intended use lifetime.
Iceform liner and sleeve: Subjects will be asked to use the investigational device as their primary prosthesis for up to 6 months. TPE material durability evaluated through monthly online questionnaires.
|
|---|---|
|
Number of Liners With TPE Material Failure
|
0 Liners
Standard Deviation 0
|
Adverse Events
Failure Time Analysis
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Failure Time Analysis
n=64 participants at risk
The primary objective is to evaluate the durability of the investigational device over its intended use lifetime (i.e. warranty period), specifically relating to any defect in the TPE material. Additionally, to gather information on the rate of side-effects, i.e. skin rashes, sores, etc.
Secondary objectives relate to gather information on how amputees use the liner, specifically:
* Intensity of use (days/week and hours/day)
* Alternation; i.e. switching every other day between liners
* Use of personal hygiene or cosmetic products
The following performance and safety aspects are to be verified:
• The ICEFORM line of devices are durable over their intended use lifetime.
Iceform liner and sleeve: Subjects will be asked to use the investigational device as their primary prosthesis for up to 6 months. TPE material durability evaluated through monthly online questionnaires.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Blisters and sores
|
10.9%
7/64 • Number of events 7 • 6 months
Same definition.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place